IGF::OT::IGF PHASE IB 9CUAB30 IN EARLY STAGE BREAST CANCER TO EVALUATE BIOLOGIC EFFECT

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Retinoids, which target the retinoic acid receptors (RARs), and rexinoids, which target the retinoid X receptors (RXRs), represent two classes of potential drugs with potent capacity to prevent breast cancers and have been studied extensively. 9cUAB30 is a novel RXR-selective retinoid, which is a conformationally constrained analog of 9 cis UAB30. In animal models 9cUAB30 has been shown to prevent both ER-positive and ER-negative mammary cancers with similar potency to Targretin. Additionally, modulation of proliferation and apoptosis was seen after only 7 days of treatment. Importantly gene expression array profiling has been used to demonstrate that 9cUAB30 is not an agonist in liver, which is the desired hallmark of a tissue-selective rexinoid. This single arm phase IB study is designed to determine if 9cUAB30 at the selected dose modifies breast tissue biomarkers. Therefore, this statement of work outlines the requirements for the study, including (but not limited to) participant accrual, agent administration and patient follow-up as well as associated biomarker analyses. This statement of work includes protocol activities to screen 80 participants and enroll 40 on trial stratified by ER status of the tumor as well as perform biomarkers on matched control cases.